Kornimate/medical-research-clean huggingface dataset:
study of depression, peptides, and steroids in cushing's syndrome

Conditions: Cushing's Syndrome

Summary: objectives: i. study the relationship between dysregulation of the hypothalamic-pituitary-adrenal (hpa) axis and disorders of mood, vegetative function, and cognition in patients with cushing's disease. ii. identify subgroups of patients with cushing's disease who differ in the presence and severity of the depressive syndrome, and uncover hpa axis dysregulation differences among them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.

protocol outline: all patients receive a psychiatric evaluation at baseline, as well as assessments of plasma adrenocorticotropin, beta lipotropin, beta endorphin, and cortisol, and urinary cortisol. peptide and steroid assays are performed, alone and in response to corticotropin-releasing hormone, metyrapone, and dexamethasone. patients are given sleep electroencephalograms at baseline and 1 year following treatment. a weight maintenance diet is prescribed for all patients.

Eligibility criteria:
protocol entry criteria: * patients aged 20 to 60 with spontaneous active cushing's syndrome * at least 2 weeks since medication with psychoactive effects or influence on cortisol metabolism by hepatic hydroxylating enzyme induction * antihypertensives allowed for severe hypertension * no barbiturates * no phenytoin

Keywords: cushing's syndrome endocrine disorders rare disease
urdu version of questionnaire for female urinary incontinence diagnosis: reliability and validity study

Conditions: Urinary Incontinence

Summary: the main objective of this study will be to translate and culturally adapt questionnaire for female urinary incontinence diagnosis into the urdu language and to evaluate its reliability and validity in the pakistani urinary incontinence population. also assess its correlation with pelvic floor impact questionnaire, pelvic floor distress inventory, international consultation on incontinence questionnaire-short form for severity and also check the quality of life.

according to the previous recommendation, questionnaire for female urinary incontinence diagnosis will be translated into the urdu language from its original english version and adapted culturally in pakistan. amongst the urinary incontinence population, questionnaire for female urinary incontinence diagnosis will be distributed in 200 patients who would be recruited by a convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing the informed consent forms. to test the inter-observer reliability and intra-observer reliability of the pelvic floor impact questionnaire, pelvic floor distress inventory, international consultation on incontinence questionnaire-short form questionnaires will be completed by two observers, on the same day, with a time interval of 2 hours between first and second distribution. for the 3rd assessment, questionnaires will be completed after 7 days by the first observer, for intra-observer assessment. statistical package of social sciences software version 24 will be used for the purpose of data entry and analysis. internal consistency will be analyzed by cronbach alpha value. test-retest reliability will be assessed by using an intra-class correlation coefficient. the questionnaire for female urinary incontinence diagnosis will be evaluated for content validity, construct validity, criterion validity, and responsiveness.

Eligibility criteria:
inclusion criteria: * women age 18 years or above. * women who answered 'yes' to one or both of the following questions: "in the last month have your urine leaked involuntarily when you lifted weights, exercised, sneezed or coughed?" and "in the last month, have you sensed very strong urge to urinate, leaking urine before getting into the bathroom?" exclusion criteria: * current pregnancy or 3 months postpartum * any neurological disease * urinary tract infection, urogenital cancer, interstitial cystitis * taking treatment for pfd in the last 3 months

Keywords: urinary incontinence questionnaire for female urinary incontinence diagnosis cultural adaptation validity urdu version reliability pelvic floor distress inventory
adolescence and diabetes:can an automated closed loop system improve control ?

Conditions: Type1 Diabetes Mellitus

Summary: this study evaluates the use of the fd2 automated closed loop insulin administration in adolescents with a poor metabolic control . all youth will be treated in a random order by their usual pump treatment or an automated system and we will evaluate whether this has an impact on metabolic control and sleep

achievement of a good metabolic control is very important for all persons with diabetes . in adolescence many changes occur , physically , socially and psychologically .this may influence the metabolic control . this study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control. it is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (cl) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (csii) in the home setting in poorly controlled type 1 diabetes adolescents.

Eligibility criteria:
inclusion criteria: 12- 18 years type 1 diabetes according to who/ispad , for at least 1 year csii treatment for at least 6 month hba1c ≥ 8,0%, for more than 6 months informed consent of the patient and parents exclusion criteria: non-type 1 diabetes mellitus including those secondary to chronic disease any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator. current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator known or suspected allergy against insulin recurrent incidents of severe hypoglycaemia as defined by ispad guidelines during the previous 12 months. more than one episode of diabetic ketoacidosis (dka) as defined by ispad in preceding 12 months -
evaluating the fade to fitness program: a barbershop-based program for black men

Conditions: Health Related Quality of Life

Summary: the fade to fitness program is a targeted intervention designed to improve the holistic health and quality of life among black men. this comprehensive initiative focuses on four key health behaviors: physical activity, healthy eating, stress management, and depression management. it is grounded in psychological and social theories like self-determination theory, motivational interviewing, and social cognitive theory. the program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere. the program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle.


Eligibility criteria:
inclusion criteria: * self-identify as african american or black american male - 18 - 90 years of age * able to speak and understand english exclusion criteria: * currently participating in another health promotion intervention * on a special diet for a serious health condition * intending to move within 6 months of participating in the intervention
comparative effectiveness trial of two supportive cancer care delivery models for adults with cancer

Conditions: End of Life; Cancer

Summary: this cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (scc) approach with a redesigned team-based supportive cancer care (scc) approach.

primary objectives: i. greater intervention effects on health-related quality of life secondary objectives: i. greater intervention effects on patient activation ii. greater satisfaction with care and decision-making iii. greater documentation of goals of care and symptoms iv. to lower acute care v. greater palliative care and hospice outline: sites are randomized to 1 of 2 arms. arm a: patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12. arm b: patients are paired with a lay health worker who will discuss the same educational materials from arm a either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12. all participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease. 2. patients must have the ability to understand and willingness to provide verbal consent. 3. participants must speak english, spanish, chinese, or vietnamese. exclusion criteria: 1. inability to consent to the study 2. plans to change oncologist within 12 months 3. employed by the practice site 4. patients who anticipate moving from the area within 12 months

Keywords: carcinoma lung neoplasms carcinoma, non-small-cell lung melanoma pancreatic neoplasms sarcoma ovarian neoplasms carcinoma, ovarian epithelial stomach neoplasms glioblastoma rectal neoplasms colonic neoplasms esophageal neoplasms breast neoplasms carcinoma, renal cell skin neoplasms small cell lung carcinoma osteosarcoma myelodysplastic syndromes disease progression neoplasms, glandular and epithelial neoplasms by histologic type neoplasms respiratory tract neoplasms thoracic neoplasms neoplasms by site lung diseases respiratory tract diseases urogenital neoplasms carcinoma, bronchogenic
wave. wearable-based covid-19 markers for prediction of clinical trajectories

Conditions: COVID; COVID 19; SARS-CoV 2

Summary: the aim is to develop a wearable-based icu (intensive care unit) prediction algorithm for inpatients contracted with sars-cov-2. inpatients with suspicion of covid-19 or with confirmed sars-cov-2 infection will be included. the participants will be equipped with a smartwatch, which gathers physiological data throughout hospitalisation.

the sars-cov-2 pandemic puts an unprecedented burden on the healthcare system, specifically its healthcare providers and the resource demands for intensive care units (icus). to support effective care despite large case numbers, hospital operations urgently need improved decision support in early identification of patients at risk of an acute covid-19 deterioration that requires icu. the investigators aim at developing a wearable-based icu algorithm for inpatients contracted with sars-cov-2. inpatients on the general ward with suspicion of covid-19 or with confirmed sars-cov-2 infection will be included. the participant will be equipped with a smartwatch and wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is transferred to the icu, or (3) palliative care is initiated. the smartwatch collects several physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen saturation). the collected data will be used to develop an icu prediction algorithm to detect patients at risk of an acute covid-19 deterioration that requires icu.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age \>= 18 years * suspicion of covid-19 or patient tested positive for sars-cov-2 * hospitalisation on the general ward exclusion criteria: * smartwatch cannot be attached around the wrist of the patient * direct transfer from the emergency department or external institution to icu (i.e. no hospitalization on the general ward) * known allergies to components of the smartwatch * rejection of icu transfer in the patient decree

Keywords: smartwatch intensive care intensive care unit prediction artificial intelligence clinical trajectories
a pilot study of cyberknife radiosurgery delivered to the partial breast

Conditions: Breast Cancer

Summary: this pilot study will evaluate the technical feasibility and acute toxicity of partial breast irradiation (pbi) with the cyberknife in anticipation of a larger multi-institutional phase ii study. it will evaluate quality of life (qol) issues as they relate to treatment related side effects, cosmetic result, and patient convenience. radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the cyberknife (ck). subjects will receive ck before chemotherapy, if applicable.


Eligibility criteria:
inclusion criteria: * dcis or infiltrating ductal carcinoma of the breast \<= 3cm * margins clear by at least 2 mm * age \>=45 years exclusion criteria: * invasive lobular carcinoma * multicentric disease * nodal metastases * breast implants * pregnancy * connective tissue disease

Keywords: breast cancer partial breast irradiation radiosurgery cyberknife radiotherapy pbi
acceptability of palliative care in parkinson disease care

Conditions: Parkinson Disease

Summary: this study will assess the feasibility of using specific criteria to standardize the referral of individuals with parkinson disease to a group of medical providers known as palliative care specialists. palliative care specialists provide supportive care to individuals living with serious illnesses. the specialty focuses on providing relief from the symptoms and stress of serious illness.


Eligibility criteria:
subjects with parkinson disease: inclusion criteria: * diagnosis of idiopathic pd confirmed as most likely diagnosis with participant's treating provider * 18 years of age or older * participant or care partner able to provide informed consent * presence of one or more of the following: uncontrolled symptoms (over prior week): * depression * pain * fatigue critical events (over prior 6 months): * ≥3 falls * unintended weight loss * wheelchair dependence (\>50% of time) exclusion criteria: * diagnosis of atypical or secondary parkinsonism * outpatient palliative care visit scheduled or within the prior 6 months of the screening visit subjects who are care partners: inclusion criteria: * care partner of enrolled participant in the study * 18 years of age or older * able to provide informed consent exclusion criteria: • no care partner specific exclusion criteria
a phase iii study to evaluate the port delivery system with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: study gr40548 is a phase iii, randomized, multicenter, open-label (visual assessor \[va\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (pk) of 100mg/ml delivered via the port delivery system with ranibizumab (pds) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/ml) in participants with neovascular age-related macular degeneration (namd).


Eligibility criteria:
inclusion criteria: * age ≥50 years, at time of signing informed consent form * initial diagnosis of exudative neovascular age-related macular degeneration (namd) within 9 months prior to the screening visit * previous treatment with at least three anti-vascular endothelial growth factor (anti-vegf) intravitreal injections for namd per standard of care within 6 months prior to the screening visit * demonstrated response to prior anti-vegf intravitreal treatment since diagnosis * best-corrected visual acuity (bcva) of 34 letters or better exclusion criteria: * subfoveal fibrosis or subfoveal atrophy in study eye * subretinal hemorrhage that involves the center of the fovea in study eye * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in study eye * prior treatment with visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye * previous intraocular device implantation in study eye * previous laser (any type) used for amd treatment in study eye * treatment with anti-vegf agents other than ranibizumab within 1 month prior to the randomization visit in either eye * prior participation in a clinical trial involving anti-vegf drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye * cnv due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye * uncontrolled blood pressure * history of stroke within the last 3 months prior to informed consent * uncontrolled atrial fibrillation within 3 months of informed consent * history of myocardial infarction within the last 3 months prior to informed consent * history of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator * current systemic treatment for a confirmed active systemic infection * chronic use of oral corticosteroids * active cancer within 12 months of randomization * previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
a study of olezarsen (formerly known as akcea-apociii-lrx) administered to patients with familial chylomicronemia syndrome (fcs)

Conditions: Familial Chylomicronemia Syndrome

Summary: the purpose of the study was to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (tg) from baseline.

this was a multi-center, double-blind, phase 3 study in up to 60 patients with fcs. participants were randomized in a 2:1 ratio to receive olezarsen or matching placebo in a 53-week treatment period. the length of participation in the study was approximately 74 weeks, which included an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period. following the treatment period, eligible patients had the option to enroll in the open-label extension (ole) study isis 678354-cs13 (nct05130450).

Eligibility criteria:
key inclusion criteria: * a diagnosis of genetically confirmed familial chylomicronemia syndrome (type 1 hyperlipoproteinemia) * fasting tg ≥ 880 mg/dl (10 millimoles per liter (mmol/l) at screening * history of pancreatitis. patients without a documented history of pancreatitis are also eligible but their enrollment will be capped at 35% * stable doses of statins, omega-3 fatty acids, fibrates, or other lipid-lowering medications are allowed key exclusion criteria: * acute coronary syndrome within 6 months of screening * major surgery within 3 months of screening * have any other conditions, which, in the opinion of the investigator would make the participant unsuitable for inclusion, or could interfere with participating in or completing the study

Keywords: fcs
routine application of ostenil® mini in patients with rhizarthrosis

Conditions: Rhizarthrosis

Summary: pmcf study to observe the routine application of ostenil® mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the cmc joint.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age and in good general health condition * signed informed consent * existing ostenil® mini recommendation for the treatment of rhizarthrosis exclusion criteria: * known hypersensitivity to one of the ostenil® mini components * known pregnancy or lactating females * presence of coagulation disorder * subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts * subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
strict weight management based on glp-1 ra for ablation outcomes in overweight or obese patients with t2dm and af

Conditions: Type 2 Diabetes Mellitus (T2DM); Atrial Fibrillation (AF)

Summary: objective to compare, in patients with type 2 diabetes mellitus (t2dm) and atrial fibrillation (af) undergoing radiofrequency ablation (rfa), whether strict weight management and glycemic control based on glucagon-like peptide-1 (glp-1) receptor agonist treatment reduces the recurrence rate of atrial arrhythmias and rehospitalization rates for cardiac diseases compared to conventional post-procedural management (antiarrhythmic drugs and anticoagulants) and general antidiabetic drugs (excluding glp-1 receptor agonists). study design this trial randomly divides participants into two groups: the glp-1 receptor agonist treatment-based strict weight management and glycemic control group. the conventional treatment group


Eligibility criteria:
inclusion criteria: age \> 18 years. symptomatic atrial fibrillation (af) that has been ineffective or intolerable to at least one class i or iii antiarrhythmic drug. diagnosed with type 2 diabetes mellitus. body mass index (bmi) greater than 25 kg/m². ability to understand the purpose of the trial, willingness to participate, and signing of the informed consent form. exclusion criteria: permanent atrial fibrillation (failed cardioversion or episode duration \>12 months). previous history of af ablation treatment. history of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment. history of implantation of an implantable cardioverter-defibrillator (icd) or cardiac resynchronization therapy (crt). history of stroke or transient ischemic attack within 6 months prior to enrollment. severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc. history of left atrial appendage occlusion or planned for one-stop af ablation and left atrial appendage occlusion. pregnant, breastfeeding, or planning to become pregnant. significant bleeding tendency precluding post-procedural systemic anticoagulation. contraindications to oral hypoglycemic agents such as sglt2 inhibitors or glp-1 receptor agonists. presence of left atrial thrombus identified before the procedure. previous cardiac surgery (valve repair/replacement, coronary artery bypass grafting). unable to perform physical exercise due to illness or disability. significant hyperthyroidism or hypothyroidism. drug abuse or chronic alcoholism. comorbidity with other serious illnesses with an expected survival less than 12 months. any condition that does not align with the best interest of the subject. other conditions determined by the investigator as unsuitable for inclusion in this study, such as psychiatric disorders or psychological impairments.

Keywords: catheter ablation glucagon-like peptide-1 receptor agonist atrial fibrillation overweight obesity